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23 October 2008
Although the national blood supply provides extraordinary benefits for millions of American hospital patients each year, collecting and distributing donated blood creates remarkable difficulty and controversy (http://www.redcross.org/services/biomed/0,1082,0_320_,00.html). For example, the Food and Drug Administration has been criticized for its current policy on blood donation by homosexual men. This policy prohibits blood donation by any man who has had any sort of sexual contact with another men since the beginning of the AIDS epidemic (http://www.fda.gov/cber/faq/msmdonor.htm). Many people doubt that this exclusion criterion remains necessary to protect the blood supply from the Human Immunodefiency Virus, Hepatitis B Virus, and other infections. This paper will examine popular claims as well as scientific literature to decide whether the FDA policy can be amended to allow blood donation by some men who have had sex with other men while maintaining or improving the safety of the American blood supply. The primary safety concern considered here is transfusion-transmitted HIV infection.
What is the FDA’s current policy and rationale?
The FDA’s current policy on blood donations from men who have sex with other men as well as the rationale for this policy is easily accessible online: http://www.fda.gov/cber/faq/msmdonor.htm. This is the source of all information in this section.
The FDA began screening potential male donors for history of homosexual activity in 1983. This policy was updated in 1992 and reaffirmed in May 2007. It currently states: “Men who have had sex with other men, at any time since 1977 (the beginning of the AIDS epidemic in the United States), are currently deferred as blood donors.”
The FDA explains that blood donated by men who have had sex with men is more likely to be infected with HIV, HBV, and other diseases transmitted through bodily fluids. In fact, the HIV prevalence for men who have had sex with men is 60 times higher than the general population, 800 times higher than first time blood donors, and 8000 times higher than repeat blood donors.
Although all blood donated in the United States is tested for many diseases including HIV before it is given to patients, the FDA’s confidence in this procedure is not absolute. Testing cannot detect viruses when the levels in the blood remain very low right after transmission. Therefore, blood donated during this “window period” may falsely test negative for infection. There also remains some risk that blood will be used before testing is complete or following a positive test. Because of these testing limitations, it is important to accept blood donations with only minimal risk of HIV.
The FDA’s presentation of its policy on blood donation from men who have had sex with other men demonstrates both strengths and weaknesses. It incorporates many useful statistics on HIV incidence, prevalence, and relative risks reported by the Centers for Disease Control, a trustworthy source with access to large samples.
However, only vague evidence is provided for many other assertions. Despite the claims that “FDA scientists continue to monitor the scientific literature and consult with experts,” the policy lists only four references, all of which were more than two years old. Instead, it simply assures readers that “several scientific models” suggest that allowing donations by men who have sex with men would threaten the safety of the blood supply because “no alternate set of donor eligibility criteria” has succeeded in assessing HIV risk. Such statements do nothing to encourage further investigation by interested readers.
The FDA is also motivated to support it policy through selective inclusion of relevant facts: the online statement suggests that “many European countries” agree with the FDA and uphold the same policy for blood donation by men who have sex with other men but fails to inform readers that many other countries including France, Spain, Italy, and Sweden as well as South Africa, Russia, and Australia have found evidence sufficiently compelling to lift their bans (http://www.telegraph.co.uk/health/main.jhtml?xml=/health/2008/04/21/hmax121.xml).
Overall, the FDA’s statement of its policy on blood donation by men who have sex with other men provides a useful overview of the topic, but the information it includes is neither specific nor objective enough to satisfy the interested reader.
What other insights and opinions are presented online?
As a global resource, the internet provides abundant information about recent changes in many countries to policies on blood donation by men who have sex with other men. When Russia became the newest member of that group in May 2008, the decision was celebrated as a surprising victory in the international gay community (http://www.gaywired.com/article.cfm?id=19092§ion=67; http://www.slapupsidethehead.com/2008/05/russia-reverses-gay-blood-ban-canada-still-lags/).
Public health authorities in France, Spain, Italy, Sweden, South Africa, Australia, and Russia are widely praised for their efforts to end discrimination based on sexual orientation. One website author claims that such amendments to blood donor eligibility criteria have protected not only the rights of homosexual citizens but also the blood supply: “the number of HIV infections via blood transfusions has fallen by two thirds” in Italy and “HIV contaminations have plummeted 80 per cent” in Spain (http://www.telegraph.co.uk/health/main.jhtml?xml=/health/2008/04/21/hmax121.xml). However, the original sources of these impressive statistics could not be located to evaluate their credibility. Contrasting these seemingly successful and tolerant policies with the FDA’s is one way of voicing criticism.
Many critics assert that the FDA’s blood donation eligibility criteria are based on homophobic generalizations about men who have sex with other men. Peter Tatchell, a prominent Australian gay rights activist, writes, “What makes me really angry is the way the blanket ban on gay blood donations stereotypes all queers as the modern-day equivalent of 'Typhoid Marys'. It brands us all as one homogenous, diseased mass. . . . Why are we allowing the promotion of the homophobic myth that all queers are the bearers of contagion and death?” (http://www.petertatchell.net/blood%20ban%20on%20gays/blood%20ban%20on%20gays%20is%20homophobic.htm).
To emphasize the impropriety of the FDA’s discrimination against men who have sex with men, critics speculate about the outcry that would result if similar policies were instituted against other people groups. For example, HIV prevalence is now increasing at an alarming rate among black women (http://www.washingtonpost.com/wp-dyn/articles/A3318-2005Feb6.html), but forbidding them from blood donation because of their race and sex would be unthinkable (http://www.slapupsidethehead.com/2008/05/russia-reverses-gay-blood-ban-canada-still-lags/). One angry blogger even suggests that the FDA’s policy “makes about as much sense as refusing to hire an African American male because he’s disproportionately likely to be arrested” (http://answers.yahoo.com/question/index?qid=20070302224417AAfFfgK).
Instead, Tatchell and others believe it is important to recognize the wide variety of behaviors—both risky and protective—that members of the gay community may engage in. Some gay men may increase their risk for HIV by having unprotected sex with multiple partners. However, “many gay men stick rigorously to safer sex, such as jerking off and body rubbing, which involves virtually no chance of HIV infection. Others have been in monogamous relationships since long before the AIDS epidemic began. Some queers are even celibate!” (http://www.petertatchell.net/blood%20ban%20on%20gays/blood%20ban%20on%20gays%20is%20homophobic.htm).
Many people express confusion and alarm about the FDA’s permissive policy for blood donations by promiscuous heterosexuals. One artist criticizes the FDA for focusing on the risks associated with homosexuality while ignoring other obvious dangers. In this cartoon, the nurse cheerfully declares, “Well, you haven’t had sex with other male marsh creatures, so follow me to the donor’s chair” (http://www.slapupsidethehead.com/2008/01/). Similarly, a confounded father describes how his gay son who always uses condoms was denied the opportunity to donate blood; his straight son was permitted to donate days later, despite possible HIV exposure through unprotected sex (http://answers.yahoo.com/question/index?qid=20070302224417AAfFfgK). These people and many others seem to favor policy amendments that would defer individuals instead, regardless of sexual orientation, instead of the entire gay community based on specific sexual risks as assessed by number of partners, type of sex act, and use of condoms.
Others are outraged by the lifetime duration of the blood donation ban imposed on men who have had sex with other men. Reports of experimentation with homosexuality by young men substantiate this argument. For example, one woman evokes readers’ sympathy for her husband: although he has fathered children in a heterosexual relationship lasting more than ten years, he will never be permitted to donate blood because he had a boyfriend when he was in college (http://gaylife.about.com/b/2004/05/28/why-gay-men-cant-donate-blood.htm). Peter Tatchell expresses the same concern that “even a man whose same-sex experience is limited to a few sucks behind the bike sheds when he was a schoolboy is banned as a blood donor” (http://www.petertatchell.net/blood%20ban%20on%20gays/bloodyprejudice.htm). It seems reasonable that a man who has not developed any HIV antibodies or other symptoms months or even years after his most recent sexual encounter with another man should be permitted to donate blood. Amending the FDA policy to shorten the duration of the deferral would enlarge the pool of eligible blood donors to include some men who have had sex with other men.
How strong is online evidence against the FDA policy?
The criticism against the FDA policy for blood donations from men who have sex with other men and the arguments in favor of amendments are certainly impressive because of their number and their authors’ devotion. However, there are certainly weaknesses.
Many websites depend heavily on personal anecdotes, some of which have been recounted above. These may be effective for capturing readers’ interest, but the experiences of a few people are not sufficient cause for changing national policy.
Some online contributors attempt to support their claims with statistics, but they are often taken from unknown sources and misrepresented outside their original context. For example, the comments on one blog cite three different statistics to reach three different conclusions about HIV risk among men who have sex with other men (http://www.infektia.net/gay-men-are-not-allowed-to-donate-blood/). One person claims that black women present a greater threat to the blood supply because this group has the highest incidence of HIV in recent years. However, the high number of new cases must be considered in relation to the much higher total number of black women. Although the proportion of black women with HIV is approaching the proportion of gay men with HIV, the latter group has not been surpassed (http://www.fda.gov/cber/faq/msmdonor.htm).
Finally, readers must be aware that most online sources present evidence to support their own interests. The authors’ motivations must be considered. Many gay community forums discuss the FDA policy on blood donations from men who have sex with other men because the topic is more relevant to their readers than to the general population (http://gaylife.about.com; http://www.slapupsidethehead.com; http://www.gaywired.com). These writers are obviously sensitive to discrimination against gay men, so they oppose the ban. Other websites, like Peter Tatchell’s and numerous online petitions, are created and maintained with the promotion of gay rights as their primary goal (http://www.petertatchell.net/; http://www.bloodban.co.uk/; http://www.petitiononline.com/gdonors/petition.html; http://www.thepetitionsite.com/takeaction/395725675).
What kind of support for the FDA policy is there online?
Searches for information about the FDA policy on blood donations from men who have sex with other men reveal very little support. Nevertheless, it is important to acknowledge the minority opinion. One man who identifies himself as a member of the older generation reminds online forum participants of the incidents of transfusion-transmitted HIV which caused the FDA to adopt its current policy (http://answers.yahoo.com/question/index?qid=20061002081726AA5XgXT). Fear of repeating such tragedies causes his preference to err on the side of caution.
Another supporter expresses concerns about the accuracy with which potential donors would self-report specific sexual behaviors (http://answers.yahoo.com/question/index?qid=20070302224417AAfFfgK). Although dishonesty will always be possible, the risk would increase if the screening process were expanded to include questions difficult and intrusive questions about number of partners, recency of sexual activity, and frequency of condom use.
Both of these arguments in favor of the FDA’s policy on blood donations from men who have sex with other men have merits. However, both are offered merely as opinions in community forums. The supporters do not claim expertise in the field or cite reputable sources for their ideas.
How can scientific literature be used to assess the safety of proposed alternatives to the FDA policy?
Since all men who have sex with other men have been forbidden from donating blood in the United States since in 1983, proposed FDA policy amendments cannot be evaluated for safety through direct measurement. Even in other countries, alternative blood donor eligibility criteria are too new to properly assess their effects on blood supply safety. Instead, this paper will consider scientific evidence related to two recommendations popular in online sources.
First, many critics of the FDA’s current policy support expansion of the screening questionnaire to include questions about number of partners, type of sex act, and use of condoms. Demonstration that these behaviors can be used to reliably determine risk of HIV would make this alternative appear promising.
Second, others suggest that the deferral period for men who have sex with other men could be shortened to some length exceeding the window period during which infection cannot be detected by HIV testing. To evaluate this proposal, it is necessary to study and understand the testing procedures used for donated blood.
Could an expanded screening questionnaire assess potential donors’ risk for HIV?
A person’s risk for acquiring and transmitting HIV depends on numerous variables, not just his or her sexual orientation. Varghese, Maher, Peterman, Branson, & Steketee conducted one important study attempting to quantify the risks associated with choices regarding the partner’s HIV status, sex act, and condom use (2002). The study sought to understand not only the relative risk associated with each choice but also the absolute risks produced through combinations (Varghese et al., 2002). Extensive literature review provided estimated risk for most parameters. However, some relative risks were not available in published literature. For example, the authors were forced to use “best-guess estimates” to claim that insertive fellatio was 10 times less risky than insertive vaginal sex (Varghese et al, 2002, p. 39). The relative risks they determined are reported in the table below.
In the partner status category, the lowest risk of HIV acquisition is associated with partners who have tested negative for HIV; the risk of HIV acquisition from partners of unknown or positive HIV status are reported relative to this minimal risk for heterosexuals and men who have sex with men. In the sex act category, insertive fellatio presents the least risk for HIV acquisition and provides the baseline for relative risk reporting. Finally, the risk of HIV acquisition was determined to be 20 times greater for a sex act performed without a condom.
Varghese et al. assumed that “the per-act risk of HIV transmission from an infected male to an uninfected female during receptive vaginal sex without using a condom was 0.1%,” then determined the absolute risk of other sex acts by multiplying or dividing by the relative risk associate with each choice (2002, p. 40). The included figure makes their findings more easily understandable. It is important to note the overlapping absolute risk ranges for homosexual men and heterosexual woman. Although homosexual men engage in the riskiest sex acts which involve anal sex, a homosexual man who uses a condom while receiving fellatio from a HIV negative partner is at a lower risk for HIV acquisition than a heterosexual woman who, for example, receives fellatio from a partner who has tested negative for HIV without a condom.
Although the hierarchies of risk suggested by Varghese et al. essentially match expectations, their model quantifies complex behaviors to enable comparisons between them. This principle could become useful for the FDA’s blood donor screening to identify individuals at high risk for HIV. However, the model’s present value is limited by the accuracy of its risk assessments. As previously mentioned, Varghese et al. simply estimated the relative risks of several choices. Accurate data must be collected to confirm the relative risks of choice combinations proposed in this study before reconsidering which choices should determine whether a potential blood donor’s risk of HIV is sufficiently low.
As another example of the potential value of expanded screening for all donors, it is useful to consider the study published in 2004 of a case in which two patients who received blood donated by an 18-year-old heterosexual female acquired HIV (Phelps et al.). Based on detailed histories collected from all three individuals, researchers concluded that the donor had been infected with HIV approximately 10 days before providing her blood donation through contact with an unidentified man who was never located for HIV testing (Phelps et al., 2004). This tragic story of transfusion-transmitted HIV, only the second of its kind since the implementation of NAT screening in the United States, may have been preventable if the heterosexual donor had been asked more questions about her recent sexual history.
Can the FDA establish a deferral period that would safely allow sexually inactive gay men to donate blood?
The sensitivity and specificity of blood tests for HIV have rapidly increased in the last decade. The first screening process for HIV depended on immunoassays which test for the presence of antibodies or the antigens themselves. To better understand the course of HIV infection’s development and the dependent capabilities of these tests, Busch & Satten analyzed several sources of data, including symptomatic primary HIV infections, persons with know exposure dates, lookback investigations of recipients of seroconverting blood donors, seroconverters in high risk cohort studies, seroconverting plasma donor panels, and animal models (1997). They reported that the mean time necessary for HIV antibodies to become detectable in the blood was 65 days; the median was 46 days (Busch & Satten, 1997). However, nearly 5% of the subjects with known exposure dates did not seroconvert until more than 6 months later (Busch & Satten, 1997). Direct virus assays like those for HIV p24 antigen consistently detected infections up to two weeks faster than antibody assays (Busch & Satten, 1997). Findings like these no doubt influenced policies set by the FDA in the 1990s because the sensitivity of the tests available must be used to establish the deferral period which must elapse between exposure to a risk and safe blood donation.
In a 2002 report, Tabor & Epstein discuss the effects of nucleic acid testing (NAT) on donated blood screening and regulatory policy. NAT emerged in late 1990s as an improved testing method for HIV (Tabor & Epstein, 2002). The technology was approved by the FDA in 1999 and required at all blood establishments by 2003 (http://www.fda.gov/cber/products/testkits.htm; http://www.fda.gov/cber/tissue/hctptestreq.htm). NAT and immunoassays must still be used in combination to minimize risk of HIV in the blood supply, but the obvious superiority of NAT causes many to question the value of continued immunoassay testing. The greater sensitivity of NAT leads to fewer false-negative test results (Tabor & Epstein, 2002, p. 1233). Even more importantly, NAT testing shortens the window period during which HIV is present by undetectable to only 15 days (Phelps et al., 929). This means that long deferral periods before blood donations are accepted should no longer be necessary.
Scientific literature provides support for proposed amendments to the current FDA policy which bans men who have had sex with other men from donating blood which have garnered such popularity online.
The remarkable ability of NAT screening to detect low levels of HIV shortly after transmission occurs would allow the safety of the blood supply to be maintained if gay men who have abstained from sex for a definite time period were permitted to donate blood. This time period of abstinence could be conservatively set at approximately 3 months, a length exceeding the mean window period for HIV detection by antibody immunoassays, to provided added security.
Expanding the donor screening process to include questions about number of sexual partners, types of sex acts, and use of condoms could also become a beneficial method for including gay men at low risk for HIV while also excluding heterosexual persons at high risk. However, further research should be conducted to determine which behaviors or behavior combinations increase absolute risk of HIV acquisition above a reasonable maximum before implementing such a policy.
Busch, M. P. & Satten, G. A. (1997). Time course of viremia and antibody seroconversion following Human Immunodeficiency Virus exposure. The American Journal of Medicine, 102(5B), 117-124.
Phelps, R., Robbins, K., Liberti, T., Machuca, A., Leparc, G., Chamberland, M. K., et al. (2004). Window-period human immunodeficiency virus transmission to two recipients by an adolescent donor. Transfusion, 44, 929-933.
Tabor, E. & Epstein, J. S. (2002). NAT screening of blood and plasma donations: evolution of technology and regulatory policy. Transfusion, 42, 1230-1237.
Varghese, B., Maher, J. E., Peterman, T. A., Branson, B. M., & Steketee, R. W. (2002). Reducing the risk of sexual HIV transmission. Sexually Transmitted Diseases, 29(1), 38-43.
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